Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease

NCT07388186 | Not Yet Recruiting

• 1 other identifier: STRENGTH_CAREGIVERS_ALZ
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Informal caregivers of people with Alzheimer's disease experience high physical and psychological burden, increasing their risk of frailty, anxiety, and caregiver burnout. This randomized controlled trial aims to evaluate the effectiveness of a combined strength training and progressive muscle relaxation program compared with progressive muscle relaxation alone. The intervention will last 10 weeks, with assessments conducted at baseline, post-intervention, and at a 3-month follow-up. Primary outcomes include frailty, anxiety, and caregiver burden.

Conditions

Caregiver Burden; Anxiety; Frailty

Keywords

Frailty; Strength; Caregiver; Anxiety; Burden; Alzheimer disease

Outcome Measures

Primary Outcomes (1)

• Frailty

  Frailty will be assessed using the Short Physical Performance Battery (SPPB) and handgrip strength measured with a hand dynamometer. The SPPB includes balance, gait speed, and lower-limb strength components. The score is obtained by summing the results of three performance-based tests: balance, gait speed over 4 meters, and the five-times sit-to-stand chair test. The total score ranges from 0 to 12 points, where 0 represents the worst performance and 12 the best performance. Lower scores (generally \<10) indicate frailty and increased risk of falls. Performance is classified as follows: 0-3 (disabled), 4-6 (frail), 7-9 (prefrail), and 10-12 (independent). Handgrip strength will be measured using a hand dynamometer, and the absolute grip strength value will be recorded. The Fried frailty phenotype includes handgrip strength (dynamometry) as one of the five key criteria for identifying frailty in older adults. Cut-off values indicative of muscle weakness, adjusted for sex and body mass

  Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).

Secondary Outcomes (2)

• Anxiety

  Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)

• Caregiver burden

  Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)

Other Outcomes (2)

• Adherence to the intervention

  Throughout the 10-week intervention period

• Adverse events

  Throughout the 10-week intervention period

Study Arms (2)

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Participants in this arm will receive one weekly session of progressive muscle relaxation over a 10-week period. Each session will last approximately 45 minutes and will include diaphragmatic breathing, Jacobson's progressive muscle relaxation technique, controlled breathing exercises, and a brief cooldown period. Sessions will be supervised by a trained physiotherapist.

Behavioral: Progressive Muscle Relaxation

Strength Training plus Progressive Muscle Relaxation

EXPERIMENTAL

Participants in this arm will receive a combined intervention consisting of one weekly session of progressive muscle relaxation and one weekly session of functional strength training over a 10-week period. Strength training sessions will focus on upper limb, lower limb, and core muscle groups using progressive resistance. Each session will last approximately 45 minutes and will be supervised by a trained physiotherapist.

Behavioral: Progressive Muscle Relaxation; Behavioral: Functional Strength Training

Interventions

Functional Strength Training BEHAVIORAL

Functional strength training will be delivered in weekly supervised sessions over a 10-week period. Sessions will last approximately 45 minutes and will focus on improving upper limb, lower limb, and core muscle strength using progressive resistance exercises. Training intensity will be gradually increased according to participant tolerance and performance. All sessions will be supervised by a trained physiotherapist.

Strength Training plus Progressive Muscle Relaxation

Progressive Muscle Relaxation BEHAVIORAL

Progressive muscle relaxation will be delivered in weekly supervised sessions over a 10-week period. Each session will last approximately 45 minutes and will include diaphragmatic breathing, systematic muscle contraction and relaxation following Jacobson's technique, controlled breathing exercises, and a brief cooldown period. The intervention will be administered by a trained physiotherapist in a group setting.

Progressive Muscle Relaxation; Strength Training plus Progressive Muscle Relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Informal caregivers of a person with Alzheimer's disease
• Providing regular care for at least 10 hours per week
• Ability to attend intervention sessions
• Ability to understand and follow instructions
• Provision of written informed consent

You may not qualify if:

• Acute illness or medical conditions contraindicating participation in strength exercise
• Participation in structured exercise programs that may interfere with study outcomes
• Severe or uncontrolled psychiatric disorders
• Physical limitations preventing completion of functional assessments

Sponsors & Collaborators

• CRE Alzheimer del Imserso: collaborator
• University of Salamanca: lead
• Colegio Profesional de Fisioterapeutas de Castilla y León: collaborator

Study Sites (1)

Universidad de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Frailty; Caregiver Burden; Anxiety Disorders; Alzheimer Disease

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Andrea Calleja Caballero, Principal Investigator

CONTACT

+34 616957689; andreacallejac@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: Participants will be randomly assigned to one of two parallel intervention arms and will receive either progressive muscle relaxation alone or a combined program of functional strength training and progressive muscle relaxation over a 10-week period.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)